NxStage System One with NxView
Device Facts
| Record ID | K252377 |
|---|---|
| Device Name | NxStage System One with NxView |
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC |
| Product Code | KDI · Gastroenterology, Urology |
| Decision Date | May 15, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5860 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The NxStage System One is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The NxStage System One is also indicated for Therapeutic Plasma Exchange in a clinical environment. All treatments must be administered under physician’s prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician. NxView is a computer-based touch screen user interface that provides online instructions for use, summarized system information and remote access. NxView is contraindicated as the sole method of monitoring a patient during treatment.
Device Story
System comprises electromechanical cycler, sterile single-use extracorporeal blood/fluid circuit, and NxView touch screen interface. Cycler performs hemofiltration, hemodialysis, ultrafiltration, or plasma exchange. NxView provides online instructions, system status, and remote access to treatment logs/trends; does not control cycler. TherapyWise, an optional web-based tool, aggregates performance data from NxView for remote clinician dashboard viewing and configuration of non-critical settings (e.g., sounds). Used in acute/chronic care facilities by trained personnel. Output assists clinicians in monitoring therapy progress and program quality improvement. Benefits include improved access to treatment data and operational efficiency.
Clinical Evidence
No clinical studies were performed. Evidence consists of software verification and validation testing, including functional performance and regression testing.
Technological Characteristics
Electromechanical control unit with 12.1" resistive touch screen interface. Connectivity via LAN/Wi-Fi for remote data access. Software-based analytics tool (TherapyWise) for quality monitoring. Hardware specifications (Intel Atom/Pentium processors, 1-4GB RAM) remain unchanged from predicate.
Indications for Use
Indicated for patients with acute or chronic renal failure or fluid overload requiring hemofiltration, hemodialysis, or ultrafiltration in acute/chronic care facilities, and for Therapeutic Plasma Exchange in clinical environments. Contraindicated as the sole method of patient monitoring.
Regulatory Classification
Identification
A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.). (3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
Special Controls
*Classification.* Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ” (2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,” (3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,” (4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and (5) “Guidance for Hemodialyzer Reuse Labeling.”
Predicate Devices
- NxStage System One with NxView (K133547)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
May 15, 2026
Fresenius Medical Care Renal Therapies Group, LLC
Caitlin Kalda
Senior Lead Regulatory Affairs - Home
920 Winter St
Waltham, Massachusetts 02451
Re: K252377
Trade/Device Name: NxStage System One with NxView
Regulation Number: 21 CFR 876.5860
Regulation Name: High Permeability Hemodialysis System
Regulatory Class: Class II
Product Code: KDI
Dated: April 14, 2026
Received: April 14, 2026
Dear Caitlin Kalda:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K252377 - Caitlin Kalda
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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K252377 - Caitlin Kalda
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Sincerely,
MAURA ROONEY -S
Maura Rooney
Assistant Director
DHT3A: Division of Renal, Gastrointestinal, Obesity, and Transplant Devices
OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K252377 | |
| Device Name NxStage System One with NxView | |
| Indications for Use (Describe) NxStage System One The NxStage System One is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The NxStage System One is also indicated for Therapeutic Plasma Exchange in a clinical environment. All treatments must be administered under physician’s prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician. | |
| NxView NxView is a computer-based touch screen user interface that provides online instructions for use, summarized system information and remote access. NxView is contraindicated as the sole method of monitoring a patient during treatment. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
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K252377
FRESENIUS MEDICAL CARE
NxStage System One with NxView
Traditional 510(k)
# 1. 510(K) SUMMARY
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR § 807.92.
# 1.1. Submitter's Information
Name: Fresenius Medical Care Renal Therapies Group, LLC
Address: 920 Winter Street
Waltham, MA 02451-1457
Phone: (857) 291-0009
Fax: (781) 699-9635
Contact Person: Caitlin Kalda, Senior Lead Regulatory Affairs – Home
Preparation Date: 19 August 2025
# 1.2. Device Name
Trade Name: NxStage System One with NxView
Common Name: Hemodialysis System
Regulation Name: High Permeability Hemodialysis System
Regulatory Class: Class II per 21 CFR § 876.5860
Product Code: KDI
Product Code Name: Dialyzer, high permeability with or without sealed dialysate system
FDA Review Panel: Gastroenterology/Urology
# 1.3. Legally Marketed Predicate Device
The NxStage System One with NxView (K133547) is the legally marketed predicate device. This predicate has not been subject to a design-related recall.
# 1.4. Device Description
## 1.4.1. Device Identification
The NxStage System One comprises:
- NxStage Cycler – An electromechanical control unit
- NxStage Cartridge – A sterile, single-use extracorporeal blood and fluid management circuit (with or without a pre-attached high permeability filter) that mounts integrally within the NxStage Cycler
- NxView – A flat panel touch screen interface which is mounted on top of the cycler and provides online instructions for use, summarized system information, and remote viewing of treatment information
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FRESENIUS MEDICAL CARE
NxStage System One with NxView
Traditional 510(k)
- TherapyWise is an optional feature to NxView that gives the user visual access to aggregated performance data of their account’s Renal/Kidney Replacement Therapy (RRT/KRT) program to understand how the program is running and to identify areas for improvement (i.e., staff education, competency, and proficiency)
## 1.4.2. Device Characteristics
The NxStage System One cycler is an electromechanical control unit.
NxView is a communication device that captures, stores, and displays treatment information, and device labeling instructions. It does not input or control the NxStage Cycler.
TherapyWise, an optional feature to NxView, is a secure, web-based quality analytics tool that collects data from the NxStage System One with NxView system.
## 1.4.3. Environment of Use
The NxStage System One with NxView is designed to deliver hemofiltration, hemodialysis, and/or ultrafiltration in an acute or chronic care facility. The NxStage System One with NxView is also indicated for Therapeutic Plasma Exchange in a clinical environment.
## 1.4.4. Brief Written Description of the Device
This submission is for a NxStage System One with NxView (also referred to as “NxView”) software update. The device’s operating principles and hardware remain unchanged.
NxView is a computer-based touch screen interface that provides online instructions for use, graphical trend analyses, summarized system information, and stores treatment log files. It does not input or control the NxStage System One Cycler. The additional information provided on NxView can be beneficial for an operator of longer treatments, as well as for training a new operator. NxView also provides remote viewing of treatment information using a network connection.
The key features of NxView include:
- Real-time summary of therapy progress
- Access to online operating instructions
- System alarms notification and context-sensitive help
- History and event log to facilitate charting
- Graphical tools to enable trend analysis
TherapyWise is an optional, secure, web-based quality analytics tool that collects data from the NxStage System One Critical Care system via NxView.
TherapyWise provides the following functions:
- Captures performance data from NxView
- Sends performance data to a central secure location
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#
FRESENIUS MEDICAL CARE
NxStage System One with NxView Traditional 510(k)
- Formats the data into a user-friendly dashboard for secure presentation through a supported web browser
- Provides access for clinicians to view dashboard remotely via a secure web interface
- Allows remote viewing and the configuration of NxView settings such as phone numbers, font sizes, and chimes (sounds). (Note: Only the sounds can be changed. The sounds are not able to be muted, nor is the volume able to be changed from TherapyWise.)
# 1.4.5. Materials of Use
The NxView touch screen materials are listed in Table 1.
# 1.4.6. Key Performance Specifications/Characteristics
The NxStage System One with NxView hardware is not changing; therefore, the performance specifications remain the same as the predicate device. The part numbers listed in Table 1 are the currently marketed NxView monitors on which the TherapyWise software will be supported.
Table 1: Performance Specification Summary
| Category | Item Name | NX1274 (-A)1 | NX3302-A |
| --- | --- | --- | --- |
| NxStage Product Name | Product Name | ASSY, NxView TOUCH MONITOR, TESTED AND PACKAGED | ASSY, MTP-1233 TOUCH MONITOR, TESTED AND PACKAGED, ROHS |
| Power | Power Input | +12 to +26V DC Input ± 10% | +12V to +26V DC input |
| | Power Output | N/A | N/A |
| Physical Characteristics | Dimensions | 260 x 310 x 51 (mm) | 260 x 310 x 51 (mm) |
| | Weight | 2.3 kg | 2.3 kg |
| CPU and Memory | Processor | Intel® Atom™ processor D525 1.8GHz Processor | Onboard Intel® Pentium® Processor N4200 |
| | Chipset | Integrated | Intel Apollo Lake SoC integrated |
| | Memory | 1GB Onboard DDR3 Memory 1 x 2GB DDR3 SODIMM (Innodisk M3S0-2GHJCCN9 or M3S0-2GSJCCN9) Total 3GB DDR3 Memory | 1 x 204-pin DDR3L 1866MTs SO-DIMM 4 GB |
| Display and Touch Screen Technology | LCD Panel | 12.1” 1024x768 TFT-LCD | 12.1” XGA TFT LED PANEL CMO G121X1-L03; 1024 x 768 pixels |
| | Touch Screen | 5-wire Resistive Touch Screen | Touch panel 5 wire Analog RoHS; T121S-5RB014N-0A18R0-200FH |
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FRESENIUS MEDICAL CARE
NxStage System One with NxView
Traditional 510(k)
Table 1: Performance Specification Summary
| Category | Item Name | NX1274 (-A)^{1} | NX3302-A |
| --- | --- | --- | --- |
| | Touch Controller | N/A | USB touch (EETI) |
| I/O Ports | Serial Port | 1st: DB9 RS-232 2nd: DB9 RS-232 (replaces Compact Flash on standard MTP-1205) | 2 x RS-232/422/485 |
| | USB | 2 x USB 2.0 (bottom access) 2 x USB 2.0 (side access) | Side USB 2.0 x 2 Ports Rear USB 3.0 x 4 Ports |
| | Audio | 1 x Line-Out 2 x 2W Speakers | 1 x Line-Out 2x 2W speakers |
| | LAN | N/A | 2 x RJ-45 |
| | Wireless LAN Antenna | 2 x Internal Wi-Fi Antenna | PCB Antenna 2.4/5.0GHz-IPEX Ø1.13mm 50cm x 2 |
| | Other | 1 x DB15 VGA port | 1 x HDMI |
| Shipping | Box Shipping | NC5299 BOX, SHIPPING, 17.75 X 11.38 X 15.88, 350LB BC KRAFT with shipping foam | NC5299 BOX, SHIPPING, 17.75 X 11.38 X 15.88, 350LB BC KRAFT with shipping foam |
1 Note: The NX1274 and NX1274-A are identical except that NX1274-A is RoHS compliant.
## 1.5. Intended Use
The NxStage System One with NxView is designed to deliver hemofiltration, hemodialysis, and/or ultrafiltration in an acute or chronic care facility. The NxStage System One with NxView is also indicated for Therapeutic Plasma Exchange in a clinical environment.
## 1.6. Indications for Use
The indications for use remain the same as the predicate device (K133547).
### NxStage System One
The NxStage System One is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility.
The NxStage System One is also indicated for Therapeutic Plasma Exchange in a clinical environment.
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FRESENIUS MEDICAL CARE
NxStage System One with NxView
Traditional 510(k)
All treatments must be administered under physician’s prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.
## NxView
NxView is a computer-based touch screen user interface that provides online instructions for use, summarized system information and remote access.
NxView is contraindicated as the sole method of monitoring a patient during treatment.
## 1.7. Comparison of Technological Characteristics with the Predicate Device
The following technological characteristics of the NxStage System One with NxView are substantially equivalent to those of the predicate system (K133547):
- Intended Use/Indications for Use
- Design Specifications
- Technological Characteristics
- Principle of Operation
- Performance Requirements
The proposed device differs from the predicate device regarding the following modifications:
- Software changes
Verification testing was performed to verify the safety and effectiveness of the proposed device for its intended use. Differences between the predicate and proposed device do not raise any questions of safety or effectiveness.
## 1.8. Performance Data
The following performance tests were conducted on the NxStage System One with NxView to support the determination of substantial equivalence:
- Software Verification and Validation
### 1.8.1. Biocompatibility Testing
Not applicable. No biocompatibility testing was required because the change is software only.
### 1.8.2. Human Factors Validation Testing
Not applicable. Based on the use-based risk analyses, no critical tasks are associated with the use of NxView and TherapyWise. Therefore, Human Factors Testing was not required.
### 1.8.3. Electrical Safety and Electromagnetic Compatibility (EMC)
Not applicable. No EMC or wireless technology information is needed because the change is software only.
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FRESENIUS MEDICAL CARE
NxStage System One with NxView
Traditional 510(k)
## 1.8.4. Software Verification and Validation Testing
Software verification testing was performed to demonstrate the efficacy of the software. The following testing was performed:
- Functional and Performance Verification
- Regression Testing
Software verification information within this submission is provided in accordance with the following FDA guidance documents:
- Content of Premarket Submissions for Device Software Functions (14 June 2023)
- Off-The-Shelf Software Use in Medical Devices (11 August 2023)
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (27 June 2025)
## 1.8.5. Animal Studies
No animal studies were performed in support of the software change.
## 1.8.6. Clinical Studies
No clinical studies were performed in support of the software change.
## 1.9. Conclusions
The indications for use, design, principle of operation, and technological characteristics of the NxStage System One with NxView are substantially equivalent to those of the predicate device. Test results demonstrate that the differences between the NxStage System One with NxView and the predicate do not raise new concerns with regard to safety or efficacy. FMCRTG concludes that with the meaning of the Medical Device Amendments Act of 1976, the NxStage System One with NxView is safe and effective for its intended use.
